Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances

NCT ID: NCT03447847

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-09-01

Brief Summary

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Interventional crossover study on healthy volunteers aimed at evaluating the effect of the composition and timing of ingestion of different types of water on the urinary excretion of lithogenic substances; the study will also analyze the effect of potassium citrate on urine pH and lithogenic substances

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Phase 1

A=oligomineral water, B=oligomineral water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

1 liter of water in meals; 1 liter out of meals

Phase 2

A=oligomineral water, B=bicarbonate-rich water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

1 liter of water in meals; 1 liter out of meals

Phase 3

A=bicarbonate-rich water, B=oligomineral water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

1 liter of water in meals; 1 liter out of meals

Phase 4

A=bicarbonate-rich water, B=bicarbonate-rich water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

1 liter of water in meals; 1 liter out of meals

Interventions

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Water

1 liter of water in meals; 1 liter out of meals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years

Exclusion Criteria

* Chronic malabsorption
* Recurrent urinary tract infections
* History of kidney stones
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Pietro Manuel Ferraro

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Divisione di Nefrologia, Fondazione Policlinico Gemelli

Rome, , Italy

Site Status

Countries

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Italy

References

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Ferraro PM, Baccaro R, Baroni S, D'Alessandri L, Carpenito C, Di Daniele N, Urbani A, Gambaro G. Effect of water composition and timing of ingestion on urinary lithogenic profile in healthy volunteers: a randomized crossover trial. J Nephrol. 2021 Jun;34(3):875-881. doi: 10.1007/s40620-020-00769-2. Epub 2020 Jun 8.

Reference Type DERIVED
PMID: 32514990 (View on PubMed)

Other Identifiers

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43111/16

Identifier Type: -

Identifier Source: org_study_id

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